BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11021441 · Received December 16, 2020

    Report

    Report Number
    8010047-2020-10484
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    February 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE MALFUNCTION (ELEVATOR ON DUODENOVIDEOSCOPE NOT RETRACTING DOWN) LIKELY OCCURRED DUE TO ADHERED FOREIGN OBJECT TO THE FORCEPS ELEVATOR, OR MISUSE OF THE ENDOTHERAPY ACCESSORY. ACCORDING TO SIMILAR COMPLAINT INVESTIGATION, FOREIGN OBJECT ADHERED AROUND THE FORCEPS ELEVATOR, CAUSING A DISTURBANCE TO THE MOVEMENT OF THE ELEVATOR. IN ANOTHER SIMILAR COMPLAINT, ENDOTHERAPY ACCESSORY WAS SEEMINGLY USED WHILE IT WAS IN THE WRONG POSITION AROUND THE FORCEPS ELEVATOR, WHICH LED TO A PART OF THE ELEVATOR MELTED AND DEFORMED. THE ELEVATOR MAY HAVE GOTTEN CAUGHT AT THE DEFORMED PART. A REVIEW OF THE INSTRUCTIONS FOR USE IDENTIFY PREVENTATIVE VERBIAGE TO AVOID THE SUGGESTED EVENT: - NEVER EMIT HIGH-FREQUENCY CURRENT BEFORE CONFIRMING THAT THE DISTAL END OF THE HIGH-FREQUENCY ENDOTHERAPY ACCESSORY IS IN THE ENDOSCOPE'S FIELD OF VIEW. ALSO, CONFIRM THAT THE ELECTRODE SECTION AND THE MUCUS MEMBRANE IN THE VICINITY OF THE TARGET AREA ARE AT AN APPROPRIATE DISTANCE FROM THE DISTAL END OF THE ENDOSCOPE. IF THE HIGH-FREQUENCY CURRENT IS EMITTED WHILE THE DISTAL END OF THE ENDOTHERAPY ACCESSORY IS NOT VISIBLE OR TOO CLOSE TO THE DISTAL END OF THE ENDOSCOPE, PATIENT INJURY, BLEEDING, AND / OR PERFORATION, AS WELL AS EQUIPMENT DAMAGE CAN RESULT. PER THE LEGAL MANUFACTURER, THE OTHER ISSUES IDENTIFIED IN THE INITIAL REPORT (SCRATCH FOUND ON THE C-BODY CAP, LIGHT GUIDE / MINOR CHIP, SCOPE CONNECTOR LABEL PEELING, AND K-WIRE ADJUSTMENT) HAVE NO POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THEY WERE TO RECUR, AND ARE NOT REPORTABLE PHENOMENON.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING THE EVALUATION, THE ELEVATOR WAS FOUND NOT SITTING BACK PROPERLY. A SCRATCH WAS FOUND ON THE C-BODY CAP. THE LIGHT GUIDE CONTAINED A MINOR CHIP. THE DEVICE PASSED THE FOG TEST. THE SCOPE CONNECTOR LABEL WAS FOUND PEELING. THE K-WIRE WAS ADJUSTED. NO ISSUES WERE FOUND DURING THE DEVICE INSPECTION. IF ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE ELEVATOR ON A DUODENOVIDEOSCOPE WAS NOT RETRACTING DOWN. THERE WAS NO PATIENT INVOLVEMENT OR INJURIES REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485431 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1